JP2018503419A - Interactive cardiac test data and associated devices, systems, and methods - Google Patents

Abstract

Devices, systems, and methods for assessing a patient's vasculature are provided. In some cases, the method includes obtaining external imaging data associated with the heart, obtaining cardiac test data associated with the heart, and using the external imaging data and the cardiac test data to provide a three-dimensional graphical representation of the heart. And outputting a graphical representation of the heart to a display device, the graphical representation of the heart including a graphical representation of the heart test data. Corresponding systems and devices are also provided.

Description

  The present disclosure generally relates to assessment of a patient's blood vessels and heart to determine appropriate therapeutic intervention. For example, some embodiments of the present disclosure are suitable for visualization of a three-dimensional model of the heart with nuclear stress test data, such as myocardial blood flow imaging data.

  Innovations in diagnosing and verifying the degree of success of disease treatment have progressed from simple external imaging processes to including internal diagnostic processes. In addition to conventional external imaging techniques such as X-ray, MRI, CT scan, single photon emission computed tomography (SPECT), fluoroscopy, angiography, small sensors can now be placed directly into the body. Diagnostic equipment and processes for diagnosing vascular occlusion and other vascular diseases, for example, with a micro sensor placed at the distal end of a flexible elongated member such as a catheter or guidewire used in catheterization Has been developed. For example, known medical sensing techniques include intravascular ultrasound (IVUS), forward vision IVUS (FL-IVUS), coronary flow reserve ratio (FFR) determination, Instant Wave Free Ratio ™ (iFR®) Trademark)) determination, coronary flow reserve (CFR) determination, optical coherence tomography (OCT), transesophageal echocardiography, and image guided therapy.

  When an obstructed blood vessel in need of treatment is identified, percutaneous coronary intervention (PCI) is a therapeutic procedure available to treat this blood vessel. PCI includes angioplasty and positioning a stent across a stenosis to open a blood vessel. Clinicians have traditionally relied on angiographically unrelated and physiological measurements of pressure and / or flow to plan treatment interventions. Planning a therapeutic intervention may include selecting various parameters related to the stent, such as positioning, length, diameter, and the like. Collected external cardiac test data, intravascular imaging data, and / or physiological data can be helpful in planning treatment interventions, but their effectiveness exists because they exist as separate tests Limited. For example, a clinician cannot easily visualize where in the blood vessel data was collected. Furthermore, physiological data and external cardiac test data are not integrated in a meaningful manner that would allow clinicians to assess the effects of PCI, for example, on blood flow to the myocardium.

  Thus, there remains a need for improved devices, systems, and methods for assessing the severity of vascular occlusion and, in particular, vascular stenosis. It also plans therapeutic interventions by combining external cardiac test data, physiological data, and / or intravascular imaging data to allow clinicians to efficiently plan and evaluate proposed therapies There remains a need for improved devices, systems, and methods for doing so. Furthermore, there remains a need to provide a visual depiction of blood vessels that allows clinicians to plan, evaluate, and modify the proposed therapy in a manner assisted by the collected data. .

  Embodiments of the present disclosure are configured to provide a three-dimensional graphical representation of the heart to allow a physician to effectively plan a surgical procedure known as percutaneous coronary intervention (PCI). ing. A three-dimensional model of the heart may integrate, for example, angiography, pressure measurements, intravascular ultrasound (IVUS) images, and nuclear stress test data. Nuclear stress test data indicates the amount of blood / oxygen in the heart muscle as a result of blood flow through the blood vessels or coronary arteries of the heart. Nuclear stress test data can be used to simulate the physiological effects of placing a stent in a coronary artery. A physician can efficiently plan PCI by placing a simulated stent in a three-dimensional representation of the heart and / or blood vessel and evaluating the resulting simulated physiological effects.

  In one embodiment, a method for assessing a patient's vasculature is provided. The method includes obtaining external imaging data associated with the heart; obtaining cardiac test data associated with the heart; generating a three-dimensional graphical representation of the heart using the external imaging data and the cardiac test data Outputting a graphical representation of the heart to a display device, wherein the graphical representation of the heart includes a graphical representation of cardiac test data.

  In some embodiments, acquiring external imaging data includes acquiring at least one of angiographic data and computed tomography data. In some embodiments, obtaining cardiac test data includes myocardial blood flow imaging data. In some embodiments, outputting the graphical representation of the heart to a display device includes outputting the graphical representation of the heart to at least one of a touch-sensitive display device and a holographic display device. In some embodiments, the graphical representation of the heart test data includes at least one of a pattern, shading, or color scheme that represents blood flow to the myocardium. In some embodiments, the method further comprises obtaining physiological data associated with the blood vessel. In some embodiments, obtaining the physiological data associated with the blood vessel includes obtaining at least one of a pressure measurement, a flow measurement, and a temperature measurement. In some embodiments, generating a three-dimensional graphical representation of the heart includes generating a three-dimensional graphical representation of the blood vessel; outputting the graphical representation of the heart outputs a graphical representation of the blood vessel. Including. In some embodiments, the method further includes associating cardiac test data with at least one of external imaging data and physiological data. In some embodiments, the method receives user input to simulate a therapeutic intervention; and uses the physiological data and cardiac test data to simulate the effect of the therapeutic intervention on blood flow to the myocardium. Further comprising: determining; outputting a modified graphical representation of the heart including a graphical representation of the simulated effect. In some embodiments, receiving user input to simulate a therapeutic intervention includes receiving user input to simulate a percutaneous coronary intervention. In some embodiments, receiving user input includes receiving data representing user touch input at the touch-sensitive display device and receiving a data representation of a hand gesture received by the input device. Including at least one.

  In one embodiment, a system for assessing a patient's vasculature is provided. The system comprises a first instrument sized and shaped for introduction into a patient's blood vessel; and a processing system communicatively coupled to the first instrument and the display device, the processing system comprising: a heart Receiving external imaging data related to the heart; receiving cardiac test data related to the heart; receiving physiological data related to the blood vessel from the first instrument; out of the cardiac test data and the external imaging data and physiological data Associating with at least one; generating a three-dimensional graphical representation of the heart using external imaging data, cardiac test data, and physiological data; and outputting the graphical representation of the heart to a display device, wherein The graphical representation of the heart includes a graphical representation of cardiac test data.

  In some embodiments, the external imaging data includes at least one of angiographic data and computed tomography data. In some embodiments, the cardiac test data includes myocardial blood flow imaging data. In some embodiments, the system further includes a display device, the display device including at least one of a touch sensitive display device and a holographic display device. In some embodiments, the computing device is configured to output a graphical representation of cardiac test data that includes at least one of a pattern, shading, or color scheme representing blood flow to the myocardium. In some embodiments, the physiological data associated with the blood vessel includes at least one of a pressure measurement, a flow measurement, and a temperature measurement. In some embodiments, the computing device: generating a three-dimensional graphical representation of the heart by generating a three-dimensional graphical representation of the blood vessel; outputting a graphical representation of the heart by outputting the graphical representation of the blood vessel It is configured. In some embodiments, the system further includes a second instrument sized and shaped for introduction into the patient's blood vessel, wherein the computing device is configured such that the second instrument is longitudinally within the blood vessel. And is configured to receive pressure measurements from a first instrument and a second instrument positioned in the patient's blood vessel while the first instrument is stationary in the blood vessel. In some embodiments, the computing device further: receives user input to simulate the treatment intervention; uses the physiological data and cardiac test data to simulate the effect of the treatment intervention on blood flow to the myocardium Determining and outputting a modified graphical representation of the heart including a graphical representation of the simulated effect. In some embodiments, the therapeutic intervention includes percutaneous coronary intervention. In some embodiments, the system further includes at least one of a touch-sensitive display configured to receive user touch input and an input device configured to generate data representing a hand gesture.

  Further aspects, features and advantages of the present disclosure will become apparent from the following detailed description.

  Exemplary embodiments of the present disclosure will be described with reference to the accompanying drawings.

1 is a schematic diagram of a system according to an embodiment of the present disclosure. FIG. 1 is a flow diagram of a method for assessing a patient's vasculature according to one embodiment of the present disclosure. FIG. 3 is a flow diagram of a method for assessing a patient's vasculature, according to one embodiment of the present disclosure. 2 is a visual display according to one embodiment of the present disclosure. 7 is a visual display according to another embodiment of the present disclosure. 7 is a visual display according to another embodiment of the present disclosure. 7 is a visual display according to another embodiment of the present disclosure. 7 is a visual display according to another embodiment of the present disclosure. 7 is a visual display according to another embodiment of the present disclosure.

  For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. However, it is understood that no limitation on the scope of the disclosure is intended. Changes and further modifications to the described devices, systems, and methods, as well as further applications of the principles of the present disclosure, will be fully considered and disclosed in the present disclosure as would normally occur to one of ordinary skill in the art to which this disclosure pertains. Included in In particular, features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. Be considered. However, for the sake of brevity, many repetitions of these combinations are not described separately.

  Referring to FIG. 1, a system 100 according to one embodiment of the present disclosure is shown. The system 100 evaluates the patient's vasculature or vasculature, such as to determine, plan, and / or correct a clinical response to, for example, stenosis, occlusion, or other disturbance to fluid flow. Can be configured as follows. For example, a clinician can use the system 100 to evaluate the heart and / or one or more coronary arteries. The system 100 can also be used to evaluate various cerebral blood vessels and / or peripheral blood vessels including legs, kidneys, aorta, brain, and the like. The system 100 includes a computing device 110. System 100 may also include one or more instruments 130 and 140.

  The computing device 110 generally represents any device suitable for performing the processing and analysis techniques disclosed herein. In some embodiments, computing device 110 includes a processor, random access memory, and a storage medium. In this regard, in some specific cases, computing device 110 is programmed to perform the steps associated with data acquisition and analysis described herein. Accordingly, any steps related to data acquisition, data processing, instrument control, and / or other processing or control aspects of the present disclosure are equivalent to corresponding instructions stored in a non-transitory computer readable medium accessible to the computing device. Can be executed by a computing device. In some cases, computing device 110 is a console device. In some specific cases, computing device 110 is similar to the s5 ™ Imaging System or s5i ™ Imaging System, commercially available from Volcano Corporation, respectively. In some cases, the computing device 110 is portable (eg, handheld, riding on a rotating carriage, etc.). In some cases, all or a portion of computing device 110 can be implemented as a bedside controller, and thus one or more processing steps described herein may be performed by the processing components of the bedside controller. An exemplary bedside controller is described in US Provisional Application No. 62 / 049,265, filed September 11, 2014, entitled “Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods”. Which is incorporated herein by reference in its entirety. In addition, it is understood that the arithmetic device 110 includes a plurality of arithmetic devices depending on circumstances. In this regard, different processing and / or control aspects of the present disclosure may be performed separately using a plurality of arithmetic devices, or may be performed within a predefined grouping range. Understood. The division and / or combination of processes and / or control modes described below across a plurality of arithmetic devices are within the scope of the present disclosure.

  In general, instruments 130 and 140 may be any form of device, instrument, or probe of size and shape for positioning within a blood vessel. For example, instrument 130 typically represents a guidewire, while instrument 140 generally represents a catheter. In this regard, the instrument 130 may extend through the central lumen of the instrument 140 for use within the patient's vasculature. However, in other embodiments, the instruments 130 and 140 take other forms.

  Instruments 130 and 140 may also include one or more sensors, probes, and / or other monitoring elements 132, 134, 142, and 144. Elements 132, 134, 142, and 144 include pressure, flow (velocity and / or volume), images (ultrasonic (eg, IVUS), OCT, thermal, and / or images acquired using other imaging techniques). ), Diagnostic information about the blood vessel, including one or more of temperature, other diagnostic information, and / or combinations thereof. For example, the pressure monitoring element may be a piezoresistive pressure sensor, a piezoelectric pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, a fluid column (a fluid column that communicates with a fluid column sensor, and It may be in the form of an optical pressure sensor, and / or combinations thereof, separate and / or positioned in a part of the instrument in the vicinity of the fluid column). For example, the imaging element may take the form of a rotating IVUS device, a solid IVUS device, an OCT device, a forward view IVUS (FL-IVUS) device, other suitable devices, and / or combinations thereof.

  Although FIG. 1 illustrates that the system 100 includes two instruments 130 and 140, the system 100 may include one or more instruments of size and shape for introduction into a patient's blood vessel. Understood. Similarly, although each instrument 130 and 140 is shown as including monitoring elements 132 and 134 and monitoring elements 142 and 144, respectively, various embodiments may include one or more monitoring elements. Various exemplary systems, instruments, sensors, probes, and / or other monitoring elements are described in US Patent Application No. 62 / 024,339, filed July 14, 2014, “DEVICES, SYSTEM, “AND METHODS FOR IMPROVED ACCURACY MODEL OF VESSEL ANATOMY”; “PERCUTANEOUS CORONARY INTERVENTION (PCI) PLANNING INTERFACE AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS” of US Provisional Application No. 62 / 080,023 filed on November 14, 2014 "DEVICES, SYSTEMS, AND METHODS FOR VESSEL ASSESSMENT AND INTERVENTION RECOMMENDATION" in US Provisional Application No. 62 / 089,039; "DEVICES, SYSTEMS, AND METHODS FOR IN-STENT RESTENOSIS" in US Provisional Application No. 62 / 090,251; “PREDICTION”; “PERCUTANEOUS CORONARY INTERVENTION PLANNING (PCI) PLANNING INTERFACE WITH PRESSURE DATA AND VESSEL DATA AND” of US Provisional Application No. 62 / 080,045 “ASSOCIATED DEVICES, SYSTEMS, AND METHODS”; “DIAGNOSTIC AND IMAGING DIRECTION BASED ON ANATOMICAL AND / OR PHYSIOLOGICAL PARAMETERS” in US Provisional Application No. 62 / 089,080; and “AUTOMATED IDENTIFICATION in US Provisional Application No. 62 / 089,090” AND CLASSIFICATION OF INTRAVASCULAR LESIONS, which are incorporated herein by reference in their entirety.

  System 100 includes an external imaging device 180. In various embodiments, the external imaging device 180 may be an x-ray system, angiography system, rotational angiography system, fluoroscopy system, computed tomography (CT) system, magnetic resonance imaging (MRI) system, or other suitable An imaging device and / or combinations thereof may be included. External imaging device 180 may be configured to receive imaging data of anatomical structures such as the heart and blood vessels. The imaging data can be visualized in the form of 2D and / or 3D images of the heart, blood vessels, and / or other anatomical structures.

  System 100 also includes a cardiac test imaging device 170. In general, the cardiac test imaging device 170 may be associated with any non-invasive cardiac stress test that provides an image of the heart that is indicative of heart muscle or myocardial health. In various embodiments, the cardiac test imaging device may include a nuclear medicine imaging device such as a gamma camera or a single photon emission computed tomography (SPECT) system, other suitable devices, and / or combinations thereof. The cardiac test imaging device 170 acquires myocardial blood flow imaging (MPI) data, multi-gate acquisition (MUGA) scan, radionuclide stress test, nuclear stress test, other cardiac stress data or diagnostic data, and / or combinations thereof. Can be configured to. For example, MPI data may be collected by imaging a radiopharmaceutical such as thallium in a patient's heart muscle using a SPECT system. For example, as illustrated in FIG. 8, MPI data may be visualized in the form of a series of two-dimensional images. The images show normal blood flow during exercise and rest, normal blood flow during rest but not exercise, low blood flow during rest and exercise, and / or one of the heart resulting from scar tissue. Muscle mass may be indicated by lack of blood flow (and radiopigment) in the subregion. As described herein, cardiac test data or myocardial data can also be visualized in three dimensions.

  In some embodiments, one or more of the cardiac test imaging device 170, the external imaging device 180, and / or the instruments 130 and 140 are the computing device 110, the display device 150, and / or the input, such as in the same procedure room. Located in the vicinity of one or more of the devices 160. In some embodiments, one or more of the cardiac test imaging device 170, the external imaging device 180, and / or the instruments 130 and 140 may be a computing device 110, a display device 150, and And / or spaced apart from one or more of the input devices 160. For example, cardiac test imaging device 170, external imaging device 180, and / or instruments 130 and 140 can be part of different systems that are communicatively coupled. In doing so, the computing device 160 may be configured to obtain the collected data from remote components and process the data as described herein. Cardiac test imaging device 170, external imaging device 180, and / or instruments 130 and 140 may be configured to transmit collected data to computing device 160.

  The computing device 110 may include one or more software modules 112, 114, 116, 118, 120, 122, and 124. The software module may include computer-executable instructions associated with performing the functions described herein, such as functions associated with instruments 130 and 140, cardiac test imaging device 170, and external imaging device 180. . For example, the computing device 110 may include a cardiac test module 112, an external imaging module 114, a physiological measurement module 116, an intravascular imaging module 118, and a lumen module 120. The cardiac test module 112 generates computer instructions for controlling the acquisition, reception, and processing of cardiac test data or myocardial data from the cardiac test imaging device 170, and a three-dimensional model and / or graphical representation of the cardiac test or myocardial data. Contains instructions for generating. The external imaging module 114 includes computer instructions for controlling the acquisition, reception, and processing of external imaging data from the external imaging device 180, and three-dimensional models of the heart, blood vessels, and / or other anatomical structures and / or Or instructions for generating a graphical representation.

  The physiological measurement module 116 controls one or more of the physiological measurements obtained by the instruments 130 and / or 140 to control acquisition, reception, and processing, and based on the obtained physiological measurements. Including computer instructions for calculating the physiological amount of. Physiological quantities can include pressure-related values, flow-related values, and the like. The pressure-related value is FFR (eg, the pressure ratio value calculated when the first instrument is moved relative to the second instrument in the vessel, including across at least one stenosis of the vessel), Pd / Pa (eg, the ratio of the pressure distal to the lesion and the pressure proximal to the lesion), iFR (eg, the first instrument moves second through the vessel, including across at least one stenosis of the vessel) Pressure ratio value calculated using a diagnostic window for the distance traveled relative to the instrument. Flow-related values may include coronary flow reserve or CFR (eg, maximum increment of blood flow through the coronary artery beyond normal resting amount), basal stenosis resistance index (BSR), and the like. The physiological measurement module 116 also includes computer instructions for generating a graphical representation of positions and / or values associated with physiological measurements and / or quantities.

  Intravascular imaging module 118 includes computer instructions for controlling the acquisition, reception, and processing of intravascular imaging data acquired by instruments 130 and 140. The computing device 110 may include various imaging modules for processing data associated with different imaging modalities. Intravascular imaging module 118 can provide a tertiary representation of the heart, blood vessels, and / or other anatomical structures based on intravascular imaging data including plaque structure, plaque composition, vessel size, native vessel size, etc. Computer instructions for generating the original model and / or graphical representation may also be included. In so doing, computing device 110 includes a tissue characterization module 122 that includes computer instructions for facilitating determination of plaque structure and plaque composition. Methods and systems for recognizing tissues and tissue types in both diagnostic and therapeutic applications are described, for example, in “PARALLELIZED TREE-” of US patent application Ser. US Pat. No. 6,200,268 entitled “VASCULAR PLAQUE CHARACTERIZATION”; US Pat. No. 6,381,350 entitled “INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM” US Patent No. 7,074,188 entitled "SYSTEM AND METHOD OF CHARACTERIZING VASCULAR TISSUE"; US Patent No. 7,175,597 entitled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD"; US Patent No. 7,215,802 entitled “SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION”; US entitled “SYSTEM AND METHOD FOR IDENTIFYING A VASCULAR BORDER” Patent No. 7,359,554; US Pat. No. 7,627,156 entitled “AUTOMATED LESION ANALYSIS BASED UPON AUTOMATIC PLAQUE CHARACTERIZATION ACCORDING TO A CLASSIFICATION CRITERION”; and “APPARATUS AND METHOD FOR USE OF RFID CATHETER INTELLIGENCE” U.S. Pat. No. 7,988,633, which is incorporated by reference herein in its entirety.

  Lumen module 120 includes computer instructions for controlling the acquisition, reception, and processing of lumen data acquired by instruments 130 and 140 and / or external imaging device 180. Lumen data may include a variety of information describing the blood flow region of the blood vessel, including lumen diameter, boundaries, contours, and the like. The computing device 110 may utilize the tissue characterization module 122 in conjunction with the lumen module 120 to determine information about the blood flow region of the blood vessel. Lumen module 120 may also include computer instructions for generating a three-dimensional model and / or graphical representation of the blood vessel. In some embodiments, intravascular imaging module 118 and lumen module 120 are coupled.

  Co-registration module 124 includes computer instructions for correlating or co-registering diagnostic information such as physiological measurements, calculated physiological quantities, and / or intravascular imaging data with external imaging data. In various embodiments, external imaging data may be obtained from an externally acquired angiographic image, x-ray image, CT image, PET image, MRI image, SPECT image, and / or other two-dimensional or vascular system of the patient. It can include a three-dimensional extraluminal depiction. Spatial co-registration is entitled “VASCULAR IMAGE CO-REGISTRATION” based on known pullback speed / distance, based on known starting point, based on known ending point, and / or combinations thereof. U.S. Pat. No. 7,930,014, which can be accomplished using the technique disclosed in its entirety. For example, a mechanical pullback device can be used to perform a pressure sensing procedure. The mechanical pullback device can move the pressure sensing device through the blood vessel at a constant known speed. The position and / or pressure ratio of the pressure measurement can be determined based on the pullback speed and the known position of the pressure sensing device (eg, start position, midpoint position, end position obtained from angiographic data). In some embodiments, the diagnostic information and / or data is U.S. Provisional Patent Application No. 61 / 747,480, filed December 31, 2012, entitled "SPATIAL CORRELATION OF INTRAVASCULAR IMAGES AND PHYSIOLOGICAL FEATURES". Using techniques similar to those described in, are correlated with blood vessel images. This document is incorporated herein by reference in its entirety. In some embodiments, the co-registration and / or correlation is a US Provisional Patent Application No. 61/856 filed July 19, 2013 entitled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSMENT OF VESSELS”. 509, which is hereby incorporated by reference in its entirety.

  In some embodiments, the diagnostic information and / or data is US patent application Ser. No. 14 / 144,280 filed Dec. 31, 2012 entitled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSMENT OF VESSELS”. Using techniques similar to those described in this issue, the blood vessel images are correlated. This document is incorporated herein by reference in its entirety. In some embodiments, the co-registration and / or correlation is a US Provisional Patent Application No. 61/856 filed July 19, 2013 entitled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSMENT OF VESSELS”. 509, which is hereby incorporated by reference in its entirety. In another embodiment, the co-registration and / or correlation is described in International Application No. PCT / IL2011 / 000612 filed July 28, 2011 entitled “CO-USE OF ENDOLUMINAL DATA AND EXTRALUMINAL IMAGING”. Which can be accomplished as described, which is incorporated herein by reference in its entirety. Also, in some embodiments, the co-registration and / or correlation is performed in International Application No. PCT / IL2009 / 001089 filed on November 18, 2009 entitled “IMAGE PROCESSING AND TOOL ACTUATION FOR MEDICAL PROCEDURES”. Which can be accomplished as described in this publication, which is incorporated herein by reference in its entirety. Further, in other embodiments, co-registration and / or correlation is described in US patent application Ser. No. 12 / 075,244, filed Mar. 10, 2008, entitled “IMAGING FOR USE WITH MOVING ORGANS”. Which can be accomplished as described, which is incorporated herein by reference in its entirety.

  System 100 includes a display device 150 communicatively coupled to computing device 110. In some embodiments, display device 150 is a component of computing device 110, but in other embodiments, display device 150 is separate from computing device 110. In some embodiments, display device 150 is a holographic display device configured to output a three-dimensional graphical representation of the heart, blood vessels, and / or other anatomical structures. Any suitable holographic device is within the scope of this disclosure, including self-contained monitors, projection / screen systems, head-up display systems, and the like. Holographic devices can implement principles based on moving reflective microelectromechanical systems (MEMS), laser plasma, electronic holography, and the like. In some embodiments, the display device 150 is a US Provisional Application No. 62/049 filed September 11, 2014, for example entitled “Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods”. , 265, as a bedside controller with a touch screen display. This document is incorporated herein by reference in its entirety. The bedside controller may be configured to output a two-dimensional image and / or a two-dimensional representation of a three-dimensional model of the heart, blood vessels, and / or other anatomical structures. In some embodiments, the display device 150 is a monitor or stand-alone monitor (eg, a flat panel or flat screen monitor) built into the console device. Computing device 110 may be configured to generate a visual display based on data collected by instruments 130 and 140, cardiac test imaging device 170, and / or external imaging device 180. Exemplary visual displays (eg, holographic displays output by a bedside controller, screen displays, etc.) are illustrated in FIGS. The computing device 110 may generate display data related to the visual display and provide it to the display device 150.

  System 100 includes an input device 160 communicatively coupled to computing device 110. The input device allows the user to interact with the visual display output by the display device 150. For example, a user can use an input device to provide user input for selecting, modifying, and / or manipulating all or part of a visual display. In some embodiments, the user interface device is a separate component from the display device 180. For example, the input device may be a camera configured to acquire a clinician hand gesture, such as rotation, pan, and / or zoom in / out for a three-dimensional holographic display. Any suitable camera such as an RGB camera or an infrared camera can be used. The input device may include processing equipment for interpreting hand gestures acquired by the input device. The computing device 110 may receive data representing a hand gesture. The input device can be any peripheral device including a touch sensitive pad, keyboard, mouse, trackball, and the like. In other embodiments, the user interface device is part of the display device 180. For example, user interface devices are described, for example, in US Provisional Application No. 62 / 049,265 filed September 11, 2014, entitled “Bedside Controller for Assessment of Vessels and Associated Devices, Systems, and Methods”. It can be realized as a bedside controller with a touch screen display. This document is incorporated herein by reference in its entirety. In such embodiments, the user input may be a touch input received on a touch sensitive display of the bedside controller. The computing device 110 may receive data representing user contact input.

  System 100 includes one or more sensors, probes and / or monitoring elements of instruments 130 and 140, computing device 110, cardiac test imaging device 170, external imaging device 180, display device 150, and / or input device 160. It may include various connectors, cables, interfaces, connections, etc. for communicating between them. The illustrated communication paths are exemplary in nature and should not be considered limiting in any way. In this regard, any communication path may be utilized between the components of system 100, including physical connections (including electrical, optical, and / or fluid connections), wireless connections, and / or combinations thereof. Also good. In doing so, it is understood that one or more of the components of system 100 may be capable of communicating via a wireless connection in some cases. In some cases, one or more components of system 100 and / or system 100 and other systems (e.g., a hospital or health service provider) may be connected to a network (e.g., an intranet, the Internet, a telecommunications network, And / or other network). For example, “PERCUTANEOUS CORONARY INTERVENTION (PCI) PLANNING INTERFACE AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS” of US Provisional Application No. 62 / 080,023 filed on November 14, 2014, and November 14, 2014 In the submitted US Provisional Application No. 62 / 080,045, “PERCUTANEOUS CORONARY INTERVENTION PLANNING (PCI) PLANNING INTERFACE WITH PRESSURE DATA AND VESSEL DATA AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS” describes various communication configurations. Yes. These documents are incorporated herein by reference in their entirety.

  FIG. 2 is a flow diagram illustrating a method 200 for assessing a patient's vasculature. As shown, method 200 includes a number of listed steps, but embodiments of method 200 may include additional steps before, after, and between the listed steps. In some embodiments, one or more of the listed steps may be omitted or performed in a different order. One or more steps of method 200 may be performed by computing device 110 (FIG. 1). In step 205, the method 200 includes obtaining external imaging data. For example, computing device 110 may use an external imaging device 180 (FIG. 1) to obtain angiography and / or CT images of the heart, blood vessels, and / or other anatomical structures. In step 210, the method 200 includes obtaining physiological data. For example, computing device 110 may obtain pressure, flow rate, and / or other suitable physiological data using one or both of instruments 130 and 140.

  For example, a clinician may insert a pressure sensing endovascular device such as a catheter or guidewire into the patient. In some embodiments, the clinician may use the acquired external imaging data to guide the endovascular device to a desired location within the patient's body. After the pressure sensing endovascular device is properly positioned within the patient's body, the clinician may begin collecting pressure measurements. Pressure measurements may be collected during one or more of the following procedures: FFR “spot” measurements in which hyperemia is induced at the same time the pressure sensor stays in one location; long-term hyperemia is induced and the sensor goes to the ostia FFR pullback pulled back; iFR “spot” measurement similar to FFR spot measurement but without hyperemia; and iFR pullback with FFR pullback but no hyperemia. In various embodiments, physiological measurement collection can be performed through a combination of one or more of the above-described procedures. Physiological measurements may be continuous, such as during the pullback procedure. Physiological measurements can be taken while the intravascular device is moved in one direction. Measurement collection allows the endovascular device to select within the blood vessel (eg, when the intravascular device starts and stops moving, when the intravascular device is held longer at various points along the blood vessel, etc.) It may be a non-continuous treatment, such as when it is moved. Physiological measurements can be made while the intravascular device is moved in both directions (eg, proximal and distal within the blood vessel). Regardless of how the physiological measurements were collected, co-registration can be used to ensure that the location of the measurements can be located on the angiographic image of the vessel. For example, a composite of collected physiological measurements can be generated based on the co-registered data.

  In that case, in some cases, the pressure measurement represents a pressure ratio between a fixed position in the blood vessel and a movement position of the device when the device is moved in the blood vessel. For example, in some cases, the proximal pressure measurement is acquired at a fixed position within the blood vessel, while the instrument is It is pulled back to a second position that is more proximal than the one position (ie, closer to the fixed position for proximal pressure measurement). For clarity in understanding the concepts of the present disclosure, many of the embodiments of the present disclosure are described using this arrangement. However, these concepts include, for example, “PERCUTANEOUS CORONARY INTERVENTION (PCI) PLANNING INTERFACE AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS” in US Provisional Application No. 62 / 080,023 filed on November 14, 2014, and Described in “PERCUTANEOUS CORONARY INTERVENTION PLANNING (PCI) PLANNING INTERFACE WITH PRESSURE DATA AND VESSEL DATA AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS” of US Provisional Application No. 62 / 080,045 filed on November 14, 2014 It is equally applicable to other arrangements. These documents are incorporated herein by reference in their entirety.

  In an exemplary embodiment, the processing system may collect raw physiological data such as pressure data from an intravascular device and process the data to calculate a physiological quantity such as a pressure difference or ratio. For example, the pressure difference between two pressure measurements in a blood vessel (eg, a fixed position pressure measurement and a moving pressure measurement) may in some cases (eg, a movement pressure measurement divided by a fixed position pressure measurement) 2 Calculated as the ratio of two pressure measurements. In some cases, a pressure difference is calculated for each cardiac cycle of the patient. In so doing, the calculated pressure difference is, in some embodiments, the average pressure difference in the heartbeat cycle. For example, in some cases where hyperemic agents are applied to a patient, the pressure difference is calculated using the average pressure difference in the heart cycle. In other embodiments, the pressure difference is calculated using only a portion of the heartbeat cycle. The pressure difference is in some cases the fraction of the heart cycle or the average of the diagnostic window.

  In some embodiments, the diagnostic window is described in US patent application Ser. No. 13 / 460,296, filed Apr. 30, 2012, entitled “DEVICES, SYSTEMS, AND METHODS FOR ASSESSING A VESSEL”. Selected using one or more of the following techniques. This document is incorporated herein by reference in its entirety. As discussed in that document, the diagnostic window and related techniques are particularly suitable for use without applying a hyperemic agent to the patient. In general, diagnostic windows for assessing differential pressure before and after stenosis without the use of hyperemic agents are proximal pressure measurement, distal pressure measurement, proximal velocity measurement, distal velocity measurement, ECG waveform, and Identified based on one or more features and / or components of other identifiable and / or measurable aspects of vascular function. In doing so, in order to identify an appropriate diagnostic window, proximal pressure measurement, distal pressure measurement, proximal velocity measurement, distal velocity measurement, ECG waveform, and / or other identifiable and / or measurement of vascular function Various signal processing and / or arithmetic techniques may be applied to one or more features and / or components of the possible aspects.

  Referring again to FIG. 2, at step 215, the method 200 includes obtaining intravascular imaging data. Intravascular imaging data, such as IVUS or OCT data, may be collected using one or both of instruments 130 and 140 in a manner similar to that in which physiological data is collected (step 210). For example, in some embodiments, a clinician may insert an intravascular device, such as a catheter or guidewire, with the imaging component into the patient. In some embodiments, the clinician may use external imaging data to guide the endovascular device to a desired location within the patient's body. After the intravascular device is properly positioned within the patient's body, the clinician can begin collecting imaging data. Intravascular images may be acquired continuously, such as during a pullback procedure. The intravascular imaging data may be a cross-sectional image, a forward view image, a side view image, or the like.

  In some embodiments, physiological data and / or intravascular imaging data are obtained simultaneously. For example, one or both of instruments 130 and 140 may include a pressure probe and an imaging component. When at least one of the instruments 130 and 140 is moved longitudinally through the blood vessel, the instrument may acquire both pressure measurements and intravascular images simultaneously. In some embodiments, physiological data and / or intravascular imaging data are obtained at the same time as external imaging data is acquired. Collecting external imaging data and physiological data and / or intravascular imaging data simultaneously may facilitate the above-described co-registration. For example, the collected pressure data may be co-registered to know the pressure sensing or imaging component position of the intravascular device within the blood vessel. The computing device 110 may associate the location with an intravascular image, pressure measurement, and / or pressure ratio at that location. The computing device 110 may also generate a visual display that includes each indicator representing the location of an intravascular image, pressure measurement, and / or pressure ratio, as described herein.

  In step 220, the method 200 includes obtaining lumen data. For example, the computing device 110 can determine information about a blood flow region of a blood vessel such as a lumen diameter, a boundary, and a contour using the acquired external imaging data and / or intravascular imaging data. In step 225, the method 200 includes co-registering physiological data, intravascular imaging data, and / or lumen data with external imaging data. For example, the computing device 110 may use the acquired external imaging data to co-register the acquired physiological data, intravascular imaging data, and / or lumen data to a physical location within the blood vessel.

  In step 230, the method 200 includes generating a three-dimensional model of the heart, blood vessels, and / or other anatomical structures. This model can be a data or visual representation of one or more components of the blood vessel 100. The computing device 110 is configured to generate a three-dimensional model using the acquired external imaging data, co-registered physiological data, and / or co-registered intravascular imaging data. For example, external imaging data (eg, CT, rotational angiography) can be used to generate three-dimensional information about anatomical structures such as blood vessel outer diameter, lumen diameter, position, contour, and the like. The position and / or viewing angle of the external imaging system can also be used to generate three-dimensional information. Intravascular imaging data and / or luminal data can include anatomical structures, vascular boundaries, tissue characterization, lumen diameter, lumen size, lumen diameter, lesion location, lesion severity, lesion length, etc. Can be used to generate additional three-dimensional information about the structural structure. Because intravascular imaging data and / or lumen data is co-registered, intravascular imaging data, lumen data, and / or external imaging data can be combined to produce a complete three-dimensional model. For example, the outer diameter of the blood vessel determined from the external imaging data can be combined with the internal structure of the blood vessel determined from the intravascular imaging data. Generating a three-dimensional model is described, for example, in “DEVICES, SYSTEM, AND METHODS FOR IMPROVED ACCURACY MODEL OF VESSEL ANATOMY” in US Provisional Application No. 62 / 024,339 filed on July 14, 2014. As such, it may include location information such as a blood vessel-tissue boundary, a medial-epicardial boundary, a luminal boundary or wall, blood, plaque, outer membrane, calcium, and the like. This document is incorporated herein by reference in its entirety. In some embodiments, the computing device 110 is anatomical as described, for example, in “DIAGNOSTIC AND IMAGING DIRECTION BASED ON ANATOMICAL AND / OR PHYSIOLOGICAL PARAMETERS” in US Provisional Application No. 62 / 089,080. Additional intravascular imaging and / or acquisition of physiological data may be automatically recommended to generate a more accurate assessment of the structure. This document is incorporated herein by reference in its entirety.

  In step 235, the method 200 includes outputting a three-dimensional graphical representation of the model to a display device. For example, computing device 110 may generate display data associated with the graphical representation and provide the display data to display device 150. The graphical representation can be displayed in three dimensions, such as a holographic display, or as a two-dimensional version, such as on a monitor or touch screen display. An exemplary visual display including a three-dimensional graphical representation is illustrated in FIGS. The three-dimensional graphical representation can represent the heart and coronary arteries (FIGS. 4, 7, and 9), a specific blood vessel or set of blood vessels (FIGS. 5 and 6), and / or other anatomical structures. May be included. In some embodiments, the graphical representation may include a cross-sectional view (FIG. 6) of the heart, blood vessels, and / or other anatomical structures.

  In step 240, the method 200 includes a clinician assessing the patient's vasculature. A 3D model of the heart, blood vessels, and / or other anatomical structures provides a virtual visualization and understanding of the interior of the blood vessel to determine the appropriate treatment without actually incising the blood vessel and / or patient. Provides an intuitive mechanism for doing this. For example, the clinician may interact with the three-dimensional graphical representation, eg, via input device 160, to determine the location, length, severity, and / or other characteristics of the lesion within the vessel. The clinician may also interact with the three-dimensional graphical representation to determine one or more parameters (eg, length, diameter, position) associated with the stent positioned in the blood vessel. By providing an indicator that identifies the location associated with physiological data and / or intravascular imaging data acquired in a three-dimensional graphical representation, clinicians can significantly integrate physiological data and / or intravascular imaging data. Can be used to determine one or more parameters of the PCI.

  In some embodiments, the computing device 110 automatically determines intravascular lesions, as described, for example, in US Provisional Application No. 62 / 089,090, “AUTOMATED IDENTIFICATION AND CLASSIFICATION OF INTRAVASCULAR LESIONS”. It can be specified. This document is incorporated herein by reference in its entirety. Location, classification, and / or other determined information about the lesion can be output along with a three-dimensional graphical representation of the heart and / or blood vessels. In some embodiments, computing device 110 may automatically determine that PCI is an appropriate treatment for that vessel. Angiographic data, pressure measurements, and / or other data may be used to determine the presence of vascular stenosis and the need for vascular treatment. An exemplary embodiment of determining to treat a blood vessel is described in US Provisional Application No. 62 / 089,039, "DEVICES, SYSTEMS, AND METHODS FOR VESSEL ASSESSMENT AND INTERVENTION RECOMMENDATION" Is incorporated herein by reference in its entirety.

  In step 245, the method 200 includes receiving user input and modifying the three-dimensional graphical representation. For example, the computing device 110 may receive data representing a user touch input at the touch sensitive display device. For example, the arithmetic device 100 may receive data representing a hand gesture acquired by the input device. For example, the arithmetic device 100 may receive data representing an input from a peripheral device. At that time, the user input is a peripheral device such as a mouse or a trackball for controlling a two-dimensional image displayed on a monitor (for example, a flat display), or a three-dimensional image displayed on a monitor (for example, a flat display). Mouse input to control, peripheral devices such as trackball, touch input on touch sensitive display to control 2D image displayed on monitor (eg flat display), displayed on monitor (eg flat display) Touch input on a touch-sensitive display for controlling 3D images, peripheral devices such as mice, trackballs, and / or holographic for controlling 3D images displayed in a holographic (3D) display (3D) for controlling 3D images displayed in the display B may be associated with the hand gesture graphic display area.

  The clinician may interact with and / or manipulate the three-dimensional graphical representation in various ways. The clinician may provide user input to rotate, pan, and / or zoom in / out the graphical representation. For example, the computing device 110 may receive data representing a hand gesture or contact input for rotating, panning, and / or zooming in / out for a three-dimensional graphical representation of the heart or blood vessel. The clinician can select and observe a particular portion of the anatomy. For example, if the graphical representation includes a three-dimensional model of the heart, the computing device 110 may receive user input for selecting a particular coronary artery. The clinician can select a specific view of the anatomy. For example, the computing device 110 may receive user input for viewing a horizontal or vertical cross-sectional profile of a blood vessel. The clinician may measure one or more dimensions of the anatomy. For example, the computing device 110 may receive user input for measuring the length or diameter of a blood vessel. In some embodiments, the three-dimensional graphical representation may include an indicator that represents the location within the blood vessel from which physiological data and / or intravascular imaging data was acquired. The clinician may select one or more of the indicators to observe relevant physiological data and / or intravascular imaging data.

  In step 250, the method 200 includes outputting a modified graphical representation based on user input. The computing device 110 may generate display data representing the modified graphical representation. For example, a three-dimensional graphical representation of the heart, blood vessels, and / or other anatomical structures is output with orientation, position, and / or magnification based on user input to rotate, pan, and / or zoom in / out Can be done. For example, a coronary artery can be output when a particular artery is selected for a graphical representation of the heart. For example, a horizontal or vertical cross-sectional profile of a blood vessel can be output. For example, in response to user measurement input, a measurement value and / or a graphical indicator representing the measurement may be output. For example, the acquired physiological data and / or intravascular imaging data may be output to select relevant indicators in the graphical representation in response to user input.

  In step 255, the method 200 includes the clinician performing therapy based on an assessment of the patient's vasculature. For example, a clinician may perform PCI using one or more parameters (eg, length, diameter, position) of a stent determined using a three-dimensional model of the vascular anatomy. For example, blood vessel length and / or diameter measurements performed on a graphical representation can be used to select one or more parameters. In some embodiments, the computing device 110 may be, for example, “PERCUTANEOUS CORONARY INTERVENTION (PCI) PLANNING INTERFACE AND ASSOCIATED DEVICES, SYSTEMS” in US Provisional Application No. 62 / 080,023 filed Nov. 14, 2014. , AND METHODS ”and“ PERCUTANEOUS CORONARY INTERVENTION PLANNING (PCI) PLANNING INTERFACE WITH PRESSURE DATA AND VESSEL DATA AND ASSOCIATED DEVICES, SYSTEMS, AND ” As described in METHODS, it is configured to provide a simulated PCI plan to facilitate determination of one or more parameters. These documents are incorporated herein by reference in their entirety.

  FIG. 3 is a flowchart illustrating a method 300 for assessing a patient's vasculature. As shown, method 300 includes a number of listed steps, but embodiments of method 300 may include additional steps before, after, and between the listed steps. In some embodiments, one or more of the listed steps may be omitted or performed in a different order. Method 300 is similar to method 200. One or more steps of method 300 may be performed by computing device 110 (FIG. 1). Steps 305, 310, 315, 320, and 325 of method 300 are similar to steps 205, 210, 215, 220, and 225 of method 200.

  In step 330, the method 300 includes obtaining cardiac test data. For example, the computing device 110 may receive myocardial blood flow imaging (MPI) data. In some embodiments, cardiac test data is acquired before physiological data, intravascular imaging data, and / or lumen data (steps 310, 315, and 320) are collected. For example, data related to non-invasive procedures such as external imaging data and cardiac test data (steps 305 and 330) may be data that is related to invasive procedures such as physiological data, intravascular imaging data, and / or luminal data. Can be collected before. In some embodiments, cardiac test data can be acquired at the same time as external imaging data, physiological data, and / or intravascular imaging data is acquired (eg, during the same diagnostic appointment). In some embodiments, any one or more of external imaging data, physiological data, intravascular imaging data, and / or cardiac test data is acquired at a different time than others. In doing so, the computing device 110 is configured to obtain data records of previous treatments, so that three-dimensional models of the heart, blood vessels, and / or other anatomical structures were collected at different times. Can be generated from information from different sources. The computing device 110 may be communicatively coupled to a hospital or medical service delivery network that includes a data store having patient medical records, diagnostic data, and the like.

  In step 335, the method 300 includes associating cardiac test data with physiological data, intravascular imaging data, luminal data, and / or external imaging data. For example, with MPI data, computing device 110 may associate a portion of the myocardium with a corresponding portion of the coronary artery that supplies blood. That portion of the coronary artery can be identified using physiological data, intravascular imaging data, luminal data, and / or external imaging data. Corresponding portions of heart muscle can be identified using MPI data. In some embodiments, the clinician can manually associate the coronary artery with a corresponding portion of the myocardium. In some embodiments, computing device 110 may automatically determine the association. In embodiments that include MPI data, a blood flow defect may be associated with a coronary vessel that is likely to supply blood to an underflowed cardiac muscle region by means of a three-dimensional location. This association is enhanced by the identification of coronary vessels and the creation of three-dimensional structures through non-invasive imaging. As described below, computing device 110 may use the association between the coronary artery and the myocardium to predict the physiological effects of simulated PCI on blood flow to the heart muscle.

  In step 340, the method 300 includes generating a three-dimensional model of the heart. Step 340 is similar to step 230 of method 200. Step 340 further includes generating a three-dimensional model of the cardiac test data. For example, MPI data is a planar slice along various axes of the heart (eg, short axis, vertical long axis, horizontal long axis, etc.) with different sets of images for different vascular conditions (eg, stress, rest, etc.) Can be included. Exemplary MPI data is illustrated in FIG. The computing device 110 may combine the images to generate a three-dimensional model of cardiac test data. In some embodiments, computing device 110 may combine cardiac test data with physiological data, intravascular imaging data, luminal data, and / or external imaging data to generate a three-dimensional model of the heart. . For example, the heart structure indicated by the heart test data can be used to verify and / or modify the heart structure generated based on the external imaging data.

  In step 345, the method 300 includes outputting a graphical representation of the three-dimensional model to a display device. Step 345 is similar to step 235 of method 200. Step 345 further includes outputting a graphical representation of the three-dimensional model of the heart test data. The graphical representation can be displayed in three dimensions, such as a holographic display, or as a two-dimensional version, such as on an external monitor or touch screen display. An exemplary visual display including a graphical representation of cardiac test data is shown in FIGS. As shown, a graphical representation of the heart test data can be provided in addition to the graphical representation of the heart and blood vessels.

  In step 350, the method 300 includes a clinician evaluating the vasculature. Step 350 is similar to step 240 of method 200. Since the graphical representation includes cardiac test data, the clinician can further assess cardiac muscle oxygenation. Using cardiac test data and a graphical representation of the heart, the clinician can identify the portion of the heart muscle that is undergoing an unhealthy amount of blood flow, which may indicate a coronary artery lesion. Because the cardiac test data is integrated with physiological data, intravascular imaging data, and external imaging data, the clinician can make a more complete assessment of the heart. The clinician may also predict the effect of revascularization on cardiac muscle oxygenation caused by stent placement as described with respect to steps 355, 360, and 365.

  In step 355, the method 300 includes receiving user input for inserting a virtual / simulated stent in a graphical representation of the anatomy. User input is in the form of one or more hand gestures, such as when the graphical representation of the heart is a holographic display, or user contact input, such as when the graphical representation is output via a touch screen display device. Can be received. In some embodiments, computing device 110 may automatically determine parameters associated with the virtual stent, such as position, length, diameter, and the like. In other embodiments, one or more parameters may be specified and / or changed by a clinician. For example, US Patent Application No. 62 / 080,023 filed Nov. 14, 2014 “PERCUTANEOUS CORONARY INTERVENTION (PCI) PLANNING INTERFACE AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS” And “PERCUTANEOUS CORONARY INTERVENTION PLANNING (PCI) PLANNING INTERFACE WITH PRESSURE DATA AND VESSEL DATA AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS” of US Provisional Application No. 62 / 080,045 filed on November 14, 2014 Which are incorporated herein by reference in their entirety.

  In step 360, the method 300 includes determining a simulated physiological effect associated with the simulated stent. For example, the computing device 110 may determine a simulated physiological effect utilizing the association established between the coronary artery and the myocardium (step 335). The simulated stent can simulate the restoration of normal, healthy blood flow in a portion of the coronary artery. The coronary arteries supply blood to part of the heart muscle. Before the occlusion was corrected by the stent, this portion of the heart muscle may not have received a healthy amount of blood / oxygen, as shown in the heart test data and its graphical representation. With a simulated stent that restores normal, healthy blood flow, computing device 110 can determine the corresponding effect on blood / oxygen that this portion of the heart muscle receives. In some cases, the heart muscle can revert to a normal, healthy amount of blood flow / oxygenation. In some cases, such as when the patient has previously experienced an occlusion in the same coronary artery, the heart muscle may be damaged and the simulated stent may not return to a normal, healthy amount of blood flow / oxygenation. unknown. The computing device 110 may be configured to determine a simulated physiological effect based on the determined parameters (eg, length, diameter, position, etc.) of the stent. Thus, the clinician can optimize stent placement by adjusting one or more of the parameters so that normal, healthy blood flow / oxygenation is returned to the heart muscle as much as possible.

  In step 365, the method 300 includes outputting a modified graphical representation that includes a simulated stent physiological effect. The computing device 110 may generate display data representing the modified graphical representation. For example, a portion of a three-dimensional graphical representation of cardiac test data has been modified to represent normal, healthy blood flow returning as a result of placement of a simulated stent, as described with respect to FIG. obtain.

  Method 300 also includes receiving user input for interacting with and / or manipulating the three-dimensional graphical representation in the various manners described with respect to method 200. For example, the computing device 110 may receive data representing a hand gesture or touch input to rotate, pan, and / or zoom in / out for a three-dimensional graphical representation of the heart, including a graphical representation of cardiac test data. For example, the computing device 110 may receive user input for selecting a particular coronary artery to observe a cross-sectional profile of a blood vessel or the like. The computing device 110 may generate display data associated with the modified graphical representation and output the display data to the display device 150. In step 370, the method 300 includes the clinician performing therapy based on an assessment of the patient's vasculature. Step 370 is similar to step 255 of method 200.

  4-9 illustrate visual displays according to exemplary embodiments. All or part of the visual representation of FIGS. 4-9 may be a three-dimensional representation, a two-dimensional representation, and / or a two-dimensional representation of a three-dimensional model. In this regard, the visual display can be output by a display device 150 such as a holographic display device, an external display, a touch screen display device, or the like. Since computing device 110 may generate display data related to the visual display, display device 150 is configured to output a visual display based on the display data.

  Referring now to FIG. 4, there is shown a visual display 400 that includes a graphical representation 410. The graphical representation 410 includes a heart 412 and one or more coronary arteries 414 and 416. The graphical representation of the heart 412 and / or the coronary artery 414 can be a three-dimensional representation generated based on external imaging data, intravascular imaging data, and / or cardiac test data. The graphical representation of the heart 412 may be anatomically correct and / or may be a stylized version of the anatomy.

  In some embodiments, the computing device 110 may automatically identify blood vessels using external imaging data such as blood vessel contours, positions, branches, and other features. The location and / or viewing angle of an external imaging system (eg, angiography or x-ray system) can also be used to identify the blood vessel. The computing device 110 may generate display data associated with the indicator 402 that includes letters, numbers, alphanumeric characters, and / or symbolic characters. In the embodiment of FIG. 4, the indicator 402 includes an abbreviation for the identified vessel, such as “RCA” for the right coronary artery, “LCA” for the left coronary artery. Although abbreviations and specific blood vessels are used in FIG. 4, it will be understood that any suitable label may be used. In some embodiments, the user selectively activates or deactivates one or more of the signs 402 such that some or all of the signs 402 are included or not included in the visual display 400. Can be activated. The visual display 400 also includes a marker 422 that indicates a location within the blood vessel 414 that is associated with a collected physiological measurement or calculated physiological quantity. For example, the marker 422 may be the position of the pressure sensor when pressure measurements are collected. In the embodiment of FIGS. 4 and 7, the marker 422 is a line segment that traverses the blood vessel 414. In the embodiment of FIGS. 5 and 6, the marker 422 is a symbol positioned along or within the blood vessel 414. Although squares are shown in FIGS. 5 and 6, it will be understood that any suitable shape or symbol may be used. Other examples of location markers are described in US Provisional Application No. 61 / 895,909, entitled “Devices, Systems, and Methods for Vessel Assessment” and filed on October 25, 2013, This document is incorporated herein by reference in its entirety. In some embodiments, the user selectively activates or deactivates one or more of the markers 422 such that some or all of the markers 422 are included or not included in the visual display 400. Can be activated.

  Visual display 400 may include a physiological field 424. A physiological field 424 is provided adjacent to the marker 422. Only a portion of the physiological field 424 is shown in the embodiment of FIG. In various embodiments, some or all of the physiological field 424 may provide a calculated physiological quantity associated with a given location, or no part provides this. For example, the user may selectively activate or deactivate one or more of the physiological fields 424. In various embodiments, the physiological field 424 includes letters, numbers, alphanumeric characters, and / or symbolic characters. In FIG. 4, field 424 contains the numerical values associated with the pressure ratio calculation. In other embodiments, field 424 may be “FFR”, “iFR”, “Pd / Pa”, “CFR”, “Temp”, or other indicator to identify the type of quantity being displayed. May be included. Such an embodiment is described, for example, in US Provisional Application No. 61 / 895,909, filed Oct. 25, 2013, entitled “Devices, Systems, and Methods for Vessel Assessment” The literature is incorporated herein by reference in its entirety.

  The visual display 400 may include various colors, patterns, and / or other visual indicators 426 that represent physiological data. For example, indicator 426 may represent a difference between a threshold pressure ratio and an actual pressure ratio. For example, if the first color (eg, green, white, or other) is significantly above the threshold (eg, 0.90 if the threshold is 0.80 on a scale of 0.00 to 1.00) A second color (e.g., yellow, gray, or other) that is close to, but above, a threshold (e.g., on a scale of 0.00 to 1.00). Can be used to represent a value between 0.81 and 0.90), and the third color (eg, red, black, or other) is equal to or below the threshold It can be used to represent a value (for example, a value of 0.80 or less when the threshold is 0.80 on a scale of 0.00 to 1.00). It will be appreciated that any number of color combinations, scaling, categories, and / or other features may be utilized to visually represent the relative value of the pressure difference relative to the threshold. However, for the sake of brevity, the applicant does not explicitly describe a number of variations. The severity key or index 430 indicates the color 432 and its corresponding physiological value 434.

  The visual display 400 may include a visual indicator 456 associated with the automatically determined lesion location. The computing device 110 can automatically identify and classify the type of lesion, as described, for example, in “AUTOMATED IDENTIFICATION AND CLASSIFICATION OF INTRAVASCULAR LESIONS” of US Provisional Application No. 62 / 089,090. This document is incorporated herein by reference in its entirety. Because indicators 422 and 440 locate physiological data and intravascular imaging data, the clinician can easily assess the vascular system around indicator 456.

  The visual display 400 also includes a marker 440 that indicates a position within the blood vessel 414 associated with the collected intravascular imaging data. For example, the marker 400 can be the position of an IVUS or OCT component when an intravascular image is acquired. In the embodiment of FIGS. 4 and 7, the marker 440 is a line segment that traverses the blood vessel 414. In the embodiment of FIGS. 5 and 6, the marker 440 is a symbol positioned along or within the blood vessel 414. Although diamonds are shown in FIGS. 5 and 6, it will be understood that any suitable shape or symbol may be used. In some embodiments, a user may selectively activate or deactivate one or more of the markers 440 so that some or all of the markers 440 are included in the visual display 400 or not included at all. Absent.

  The visual components illustrated in FIG. 4 can be variously displayed by display device 150. For example, the holographic display device may display the heart 412, blood vessels 414, 416 and visual indicators associated therewith in three dimensions. Severity key or index 430, control options 470, and / or supplemental display 480 may be displayed in two dimensions. In so doing, the two-dimensional component may be output by the same display device as the three-dimensional component, such as a holographic display device. For example, a two-dimensional component can be displayed together with a three-dimensional component. In other embodiments, different portions of the same display device or different display devices may output 2D and 3D components. For example, the holographic display device may include a portion configured to output the heart 412 and blood vessels 414 and 416 in three dimensions, a severity key or index 430, a control option 470, and / or a supplemental display 480 in two dimensions. And a portion configured to output at the same time. In other embodiments, the display device 150 is a monitor or a touch screen display device. A two-dimensional image and / or a two-dimensional representation of a three-dimensional model associated with the heart 412 and blood vessels 414 and 416 may be displayed. Severity key or index 430, control options 470, and / or supplemental display 480 may also be displayed by a monitor or touch screen display device.

  Visual display 400 includes control options 470 such as pan control 472, zoom control 474, and rotation control 476. The three-dimensional graphical representation may be output with a desired orientation, position, and / or magnification based on user input. In some embodiments, pan control 472, zoom control 474, and rotation control 476 are selectable options in visual display 400 (eg, selected based on user touch input on a touch sensitive display). In some embodiments, pan control 472, zoom control 474, and rotation control 476 are not explicitly provided, the clinician provides user contact input, and computing device 110 displays the user contact input in a graphical representation. Correlate to the desired correction. In other embodiments, instead of or in addition to pan control 472, zoom control 474, and rotation control 476, the clinician swipes left and right with a hand gesture (eg, hand or finger to pan and rotate). Can be used to display a graphical representation of the desired orientation, position, and / or magnification.

  Visual display 400 includes a measurement field 478. In some embodiments, selecting a measurement field may allow the clinician to use a 1 It may be possible to measure more than one dimension. In some embodiments, the measurement field is not explicitly provided, the clinician provides user contact input (eg, draws a line or circle), and the computing device 110 may provide the user contact input in a graphical representation desired. Correlate with corrections. In other embodiments, instead of or in addition to the measurement field, the clinician may measure one or more dimensions of the anatomy using hand gestures (eg, drawing lines or circles). The computing device 110 may utilize external imaging data, intravascular imaging data, physiological data, and / or cardiac test data to correlate dimensions in the graphical representation with actual anatomical values. The visual display 400 may include a measurement indicator 462 that indicates the dimension being measured. The visual display 400 may also include a measurement value 464 that provides a numerical value associated with the measurement.

  Visual display 400 includes supplemental display 480. The supplemental display 480 includes one or more fields that provide additional graphical representations, such as acquired physiological data, external imaging data, intravascular imaging data, and / or cardiac test data. For example, selecting one of indicators 422 and / or 440 may provide relevant physiological data in physiological field 482 and / or relevant intravascular imaging data in imaging field 484. In FIG. 4, indicators 422 and 440 surrounded by selection fields 452 and 454 are selected. Physiological values (FFR values in the illustrated embodiment) and intravascular images (eg, IVUS images in the illustrated embodiment) are provided in the physiological field 482 and the imaging field 484. FIG. 8 illustrates a supplemental display 480 that includes a cardiac test field 486. In the illustrated embodiment, a myocardial blood flow image acquired by a SPECT camera is provided.

  Referring again to FIG. 4, by providing indicators 422 and 440 in visual display 400, the clinician can make a more accurate measurement of lesion length and / or lumen diameter. The lesion length and / or lumen diameter is then used to select the stent length and diameter during PCI planning. For example, an indicator 440 associated with intravascular images of the proximal and distal ends of the lesion can be selected. By observing the intravascular image, the shoulder of the lesion can be accurately identified. The clinician can then measure the length from the proximal shoulder to the distal shoulder to determine the length of the stent. Similarly, the diameter of the stent can be selected using the lumen diameter measured at the proximal or distal shoulder. The stent length can also be selected to compensate for the hypotension caused by the lesion, as indicated by physiological data.

  Referring to FIG. 5, a visual display 500 including a three-dimensional graphical representation 510 of a blood vessel is shown. The graphical representation 510 includes the blood vessel 414 of the graphical representation 410 (FIG. 4). A three-dimensional graphical representation of the blood vessel can be generated based on the acquired external imaging data and intravascular imaging data. For example, a three-dimensional model of blood vessel 414 may include the location, contour, and other features of lesion 502. A visual display 500 may be output by the display device 150 in response to user input to isolate and observe a particular blood vessel (eg, separate from surrounding anatomy such as the heart). The clinician can switch between a visual display 400 that includes a graphical representation of blood vessels 414 and heart 412 and a visual display 500 that includes only blood vessels 414. Viewing the visual display 500 (as opposed to the visual display 400) may facilitate PCI planning when it is known that a lesion 502 is present in the blood vessel 414. For example, the clinician can more easily select indicators 422 and 440 around the lesion 502 to observe the associated physiological data and / or intravascular imaging data. The clinician can also more easily measure the dimensions associated with blood vessel 414 to determine stent parameters. Indicators 422 and 440 may be provided at various locations along vessel 414 corresponding to the path of the pressure probe and / or imaging component through vessel 414. For example, the pressure probe and / or imaging component may be near or far from the luminal boundary of the blood vessel 414.

  Referring to FIG. 6, there is shown a visual display 600 that includes a three-dimensional graphical representation 610 of a blood vessel cross section. FIG. 6 illustrates a vertical cross section of blood vessel 414. In other embodiments, computing device 110 may generate display data related to the horizontal cross section of blood vessel 414. Graphical representation 610 includes graphical representation 410 (FIG. 4) and blood vessel 414 of graphical representation 410 (FIG. 5). A three-dimensional graphical representation of the blood vessel can be generated based on the acquired external imaging data and intravascular imaging data. For example, a three-dimensional cross-sectional model of blood vessel 414 may include the location, contour, plaque structure, plaque composition, and other features of lesion 502, including plaque compositions 602 and 604. Observing visual display 600 may facilitate PCI planning. For example, the clinician can more easily select indicators 422 and 440 around the lesion 502 to observe the associated physiological data and / or intravascular imaging data. Clinicians can also more easily measure dimensions associated with blood vessels 414, such as lesion length and / or lumen diameter, to determine stent parameters. Indicators 422 and 440 may be provided at various locations along vessel 414 corresponding to the path of the pressure probe and / or imaging component through vessel 414. For example, the pressure probe and / or imaging component may be near or far from the luminal boundary of the blood vessel 414.

  Referring to FIG. 7, a visual display 700 is shown that includes a three-dimensional graphical representation 710 of the heart, such as a graphical representation of cardiac test data. A graphical representation of cardiac test data may be generated based on external imaging data and / or cardiac test data. Exemplary myocardial blood flow imaging data is illustrated in FIG. The graphical representation 710 includes a heart 412 having a color scheme, shading, pattern, or other suitable visual indicator that represents blood flow to the myocardium or heart muscle. The indicator may be graduated to illustrate the amount of blood flow to the heart muscle and / or differences in heart muscle oxygenation. For example, region 702 may represent normal, healthy blood flow / oxygenation. Region 704 that is visualized with a dark color scheme in the illustrated embodiment may represent less blood flow / oxygenation than normal. A region 706 visualized with a darker color scheme may represent damaged heart tissue with very poor blood flow / oxygenation. In different embodiments, various schemes of toned color schemes, patterns, and / or shades may be used. Region 704 may be the result of occlusion of blood vessel 414. Region 706 may represent tissue that has been damaged due to the patient's previous heart attack.

  Control option 470 may include a stent insertion field 479. The selection of the stent insertion field 479 may be user input to modify the visual representation 710 to insert a graphical representation of the stent, for example in the graphical representation of the blood vessel 414. As illustrated in FIG. 9, the graphical representation of blood vessel 414 includes stents 710 and 712. Stent parameters (eg, length, diameter, position) may be determined automatically by the computing device 110 or may be manually entered by a clinician. The computing device 110 may determine the simulated physiological effect of a given length and diameter stent at a given location being placed in a blood vessel. For example, placement of stents 710 and / or 712 may cause region 704 to have normal blood flow / oxygenation based on the association of blood vessel 414 with cardiac tissue. However, region 706 does not return to normal blood flow / oxygenation because the tissue has been damaged by the patient's previous occlusion. The graphical representation of the simulated physiological effect may be modified based on the stent 710 and 712 parameters. Accordingly, the clinician uses the visual display 900 to optimize the PCI by optimizing the length, diameter, and / or position of the stents 710 and 712 to return the myocardium to normal blood flow / oxygenation as much as possible. Can make plans. The supplemental display 480 of FIGS. 7 and 9 may provide physiological data or quantities, intravascular imaging data, and / or cardiac test data, as shown in FIGS. 4-6 and 8. As described herein, physiological data or quantity and / or intravascular imaging data is responsive to user input to select an indicator associated with physiological data and / or intravascular imaging. Can be provided. For example, cardiac test data may be provided to select a portion of the graphical representation of the heart 412 in response to user input. Cardiac test data, such as SPECT data corresponding to a selected area of the heart, can be displayed in supplemental display 480.

  In some embodiments, the visual representation of physiological data, intravascular imaging data, and / or cardiac test data provided for a three-dimensional graphical representation of the heart and / or blood vessel can be selectively displayed 1 It can be associated with more than one layer. For example, indicator 422, physiology field 424, and / or indicator 426 may be part of a physiological data layer. Indicator 440 may be part of an intravascular imaging layer. Regions 702, 704, and 706 may be part of the cardiac test data layer. The visual representation associated with each layer may be shown / hidden in response to user input and received at input device 160, for example. Also, the specific visual representation and its features included in each layer can be selected by user input.

  Those skilled in the art will also recognize that the above-described devices, systems, and methods can be varied in many ways. Accordingly, those of ordinary skill in the art will appreciate that the embodiments encompassed by this disclosure are not limited to the specific exemplary embodiments described above. While exemplary embodiments have been shown and described in this regard, a wide range of variations, modifications, and substitutions are possible in the foregoing disclosure. It will be understood that such changes can be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and consistent with the present disclosure.

Claims (15)

A system for evaluating a patient's vasculature, the system comprising:
A computing device communicatively coupled to a display device and a first instrument sized and shaped for introduction into a patient's blood vessel, the computing device comprising:
Receive external imaging data related to the heart,
Receive heart test data related to the heart,
Receiving vascular related physiological data from the first instrument;
Associating the cardiac test data with at least one of the external imaging data and the physiological data;
Generating a three-dimensional graphical representation of the heart using the external imaging data, the heart test data, and the physiological data;
Outputting the three-dimensional graphical representation of the heart to a display device, wherein the three-dimensional graphical representation of the heart includes a graphical representation of the cardiac test data;
system. The external imaging data includes at least one of angiography data and computer tomography data.
The system of claim 1.   The system of claim 1, wherein the cardiac test data includes myocardial blood flow imaging data.   The system of claim 1, further comprising the display device, the display device including at least one of a touch-sensitive display device and a holographic display device.   The system according to claim 1, wherein the computing device outputs the three-dimensional graphical representation of the cardiac test data that includes at least one of a pattern, shading, or color scheme representing blood flow to the myocardium.   The system of claim 1, wherein the physiological data associated with a blood vessel includes at least one of a pressure measurement, a flow measurement, and a temperature measurement. The arithmetic unit is
Generate a 3D graphical representation of the heart by generating a 3D graphical representation of the blood vessels,
Outputting the three-dimensional graphical representation of the heart by outputting the three-dimensional graphical representation of the blood vessel;
The system of claim 1. The arithmetic device further includes:
Receive user input to simulate treatment interventions,
Determining the simulated effect of the therapeutic intervention on blood flow to the myocardium using the physiological data and the cardiac test data;
Outputting a modified graphical representation of the heart including a simulated graphical representation of the effect;
The system of claim 1.   The system of claim 8, wherein the therapeutic intervention comprises a percutaneous coronary intervention.   The system of claim 8, further comprising at least one of a touch sensitive display that receives user touch input and an input device that generates data representing a hand gesture.   The system of claim 1, further comprising the first instrument sized and shaped for introduction into a patient's blood vessel.   12. The apparatus of claim 11, further comprising a second instrument sized and shaped for introduction into a patient's blood vessel, wherein the computing device receives vascular related physiological data from the second instrument. system. The physiological measurement from the first and second instruments is a pressure measurement;
The first instrument rests in the blood vessel while the second instrument is moved longitudinally in the blood vessel;
The system of claim 12. A method for visualizing a patient's vasculature, the method comprising:
Acquiring external imaging data related to the heart;
Obtaining cardiac test data associated with the heart;
Generating a three-dimensional graphical representation of the heart using the external imaging data and the heart test data;
Outputting the three-dimensional graphical representation of the heart to a display device, the three-dimensional graphical representation of the heart comprising a graphical representation of the heart test data. Obtaining physiological data related to blood vessels;
Associating the cardiac test data with at least one of the external imaging data and the physiological data;
Generating the three-dimensional graphical representation of the heart includes generating a three-dimensional graphical representation of the blood vessel;
Outputting the three-dimensional graphical representation of the heart includes outputting the three-dimensional graphical representation of a blood vessel;
The method according to claim 14.

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